The IQoolTM Warm System
K号: K180375 · 2018-05-18
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申请人Braincool AB
决定日期2018-05-18
产品代码DWJ
咨询委员会CV
请注意，由于原文未提供具体内容，以下是一个示例翻译：
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产品名称：[产品名称]
公司名称：[公司名称]
FDA批准号：[FDA批准号]
510(k)申请号：[510(k)申请号]
PMA申请号：[PMA申请号]
临床试验注册号：[NCT]
PubMed ID：[PMID]
产品标识符：[标识符]
产品URL：[URL]
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请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同
器械摘要
The IQoolTM Warm System is the device name listed in this FDA 510(k) record. The listed applicant is Braincool AB. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K180375. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the The IQoolTM Warm System?
The IQoolTM Warm System is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Braincool AB. The 510(k) number is K180375.
When did The IQoolTM Warm System receive FDA 510(k) clearance?
The IQoolTM Warm System received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180375.
Who is the listed applicant for The IQoolTM Warm System?
The FDA 510(k) record lists Braincool AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for The IQoolTM Warm System?
The FDA product code for The IQoolTM Warm System is DWJ.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Braincool AB为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：DWJ）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K262089一次性保暖毯Hangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® 加温系统The Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx™ 患者安全系统Stihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861加热系统Hangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun 温度管理系统 (型号 5000)Medivance, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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